Class 1 Medicines Recall: Action Now – including out of hours Pharmacy Level Recall
Pharmacies in the UK are being advised to recall all batches of valsartan containing medicines made by Actavis Group PTC (now Accord) and Dexcel Pharma Ltd due to contamination.
Brief description of the problem
The Drug Alert EL (18)A/11 issued on 5 July 2018 is now superseded by this revised alert EL (18)A/11 – revision 1 because Actavis (now Accord) has provided new information that an additional product (Valsartan/Hydrochlorothiazide 160/12.5mg Film-Coated Tablets) is also affected and is being recalled. Accord apologises for any inconvenience this may cause.
All batches of the above products are being recalled at a European level due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.
This is an emerging issue; the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact.
Product details
| Product Name | Marketing Authorisation Holder | PL number |
|---|---|---|
| VALSARTAN 40MG CAPSULES, HARD | DEXCEL PHARMA LIMITED | PL 14017/0192 |
| VALSARTAN 80MG CAPSULES, HARD | DEXCEL PHARMA LIMITED | PL 14017/0193 |
| VALSARTAN 160MG CAPSULES, HARD | DEXCEL PHARMA LIMITED | PL 14017/0194 |
| VALSARTAN 40MG FILM-COATED TABLETS | ACTAVIS GROUP PTC EHF | PL 30306/0109 |
| VALSARTAN 80MG FILM-COATED TABLETS | ACTAVIS GROUP PTC EHF | PL 30306/0110 |
| VALSARTAN 160MG FILM-COATED TABLETS | ACTAVIS GROUP PTC EHF | PL 30306/0111 |
| VALSARTAN 320MG FILM-COATED TABLETS | ACTAVIS GROUP PTC EHF | PL 30306/0405 |
| VALSARTAN/HYDROCHLOROTHIAZIDE 160/12.5MG TABLETS | ACTAVIS GROUP PTC EHF | PL 30306/0342 |
Healthcare professionals and wholesalers
Stop supplying the products listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
If you receive queries about this issue from patients, encourage them not to stop taking their medication. They should speak to their doctor to help identify alternatives.
An investigation into other potentially impacted products is currently being undertaken and further updates will be provided as the investigation progresses.
Company contacts for further information
Dexcel:
- Cheryl Haynes – Responsible Person
- cheryl.haynes@dexcel.com
- Telephone: 01327 314830 or 07827 895061
Actavis (now Accord):
- For Actavis stock control: Customer Services Team on 0800 373573
- For medical information enquires please contact Accord Medical Information on 01271 385257
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to relevant clinics, general practitioners, hospitals and community pharmacists for information.
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Updates to this page
Last updated 10 July 2018 + show all updates
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An additional product Accord Healthcare (previously known as Actavis Group) manufactured - Valsartan/Hydrochlorothiazide 160/12.5mg Film-Coated Tablets - is also affected and is being recalled.
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First published.